BioCentury
ARTICLE | Clinical News

Long Acting rFactor lX regulatory update

July 28, 2014 7:00 AM UTC

Biogen Idec disclosed in its results for 2Q14 that Japan's Ministry of Health, Labor and Welfare (MHLW) approved Alprolix rFIXFc for hemophilia B. FDA and Health Canada approved the recombinant fusion protein consisting of human coagulation Factor IX attached to the Fc domain of human IgG1 in March. Australia approved Alprolix in May. The product has Orphan Drug status in the U.S. and Orphan Drug designation in the EU for hemophilia B (see BioCentury, March 31). ...